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HHS/FDA | RIN: 0910-AB26 | Publication ID: Fall 2003 |
Title: Blood Initiative | |
Abstract: In multiple rulemakings, the Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and blood-derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. The remaining subjects intended to be addressed in the rulemakings include: labeling of blood and blood components and donor eligibility requirements. These actions are intended to help ensure the continued safety of the Nation's blood supply. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 600 21 CFR 601 21 CFR 606 21 CFR 607 21 CFR 610 21 CFR 630 21 CFR 640 21 CFR 660 21 CFR 680 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 371 21 USC 374 42 USC 216 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 |
Legal Deadline:
None |
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Child RIN List:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
Related RINs: Related to 0910-AB76 | |
Agency Contact: Paula S. McKeever Senior Scientific Policy Analyst Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville, MD 20857-0001 Phone:301 827-1520 Fax:301 443-9718 Email: paula.mckeever@fda.hhs.gov |